PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...

The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

One of the most highly anticipated FDA decisions this month is for Alnylam Pharmaceuticals, which is seeking to expand the ...

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...

A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection ...

To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...

Phase 2b and phase 3 trials may begin in 2025 and 2026, respectively. A new drug application is anticipated for 2029. The investigational new drug application for Zabalafin Hydrogel for the ...

Ivor Elrifi, CEO of Tiziana Life Sciences, expressed enthusiasm about this milestone, stating, "We are excited to initiate this important clinical study with the support of the ALS Association grant.

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...